Harmonized guidelines for probiotics as constituents in foods and dietary supplements were on the agenda at the most recent meeting of the Food and Agriculture Organization of the United Nations and World Health Organization’s Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU).
Argentina, China and Malaysia together tabled a proposal at the CCNFSDU’s forty-fourth session in Dresden, Germany earlier this month that essentially seeks to align international regulatory frameworks for probiotics with guidelines established by the FAO/WHO.
Originally tabled in 2018, the proposal has been reformulated to address contributions to the initial debate, as well as the concerns from delegations that took part in that debate.
“The proposal aims to align with the 2001 FAO/WHO guidelines by providing a harmonized definition of probiotics and establishing minimum safety and characterization requirements,” according to food regulation expert Francisco Jiménez.
“Importantly, it avoids creating a definitive list of ‘approved’ or ‘disapproved’ probiotic strains, focusing instead on providing a flexible framework for regulators to assess probiotics when regulated as foods,” said Jiménez, who is CEO of consultancy FJS International Solutions.
Health Claims
The 2001 FAO/WHO Guidelines for the Evaluation of Probiotics in Food provide a methodology for use in the evaluation of probiotics and define the criteria and specific levels of scientific evidence needed to make health claims for probiotic foods.
“The regulatory status of probiotics as a component in food is currently not established on an international basis,” the guideline notes. “In only a few countries, regulatory procedures are in place or sufficiently developed to enable probiotic products to be allowed to describe specific health benefits.”
Over 20 years later, the situation remains much the same. In the European Union, for example, where the term “probiotic” is considered an unauthorized health claim, EU member states have been going their own way.
Most recently, France has allowed gut-beneficial live organisms in dietary supplements to be sold as “probiotics,” joining Italy, the Czech Republic, Spain, Denmark, the Netherlands, Bulgaria, Malta and Poland in striking out from the European Commission’s conservative position.
One of the recommendations that the FAO/WHO guideline makes is that manufacturers should be able to make health and even disease-related claims for specific probiotic strains where there is scientific evidence, such as for gastrointestinal infections, certain bowel disorders, allergy, and urogenital infections.
In terms of general health claims, the current FAO/WHO guideline notes that “there is emerging evidence to indicate that probiotics can be taken by otherwise healthy people as a means to prevent certain diseases and modulate host immunity.”
Hotly Debated
Argentina, China and Malaysia’s suggestion to base international harmonization on the FAO/WHO guideline represents a significant departure from the status quo – indicated by the significant debate that this proposal generated at the CCNFSDU meeting.
“The recent debate in the CCNFSDU44 plenary showcased diverse perspectives, with notable support from multiple countries. Malaysia, China, Indonesia, India, Singapore, Senegal, Saudi Arabia, Egypt, Vietnam, Iran, Paraguay, and Uganda have all voiced strong backing for the initiative,” Jiménez reported.
“Their emphasis lies on the proposal’s pivotal role in boosting trade, ensuring consumer safety, and facilitating the establishment of national regulation for the use of probiotics in foods and food supplements,” he added.
However, opposition arose from the EU, UK, Canada, Norway, Switzerland, Costa Rica, and Hungary.
“These countries have raised several issues, including disagreements over the proposed definition for probiotics, concerns about overlaps with health claim evaluations, and doubts regarding the proposal’s priority,” Jiménez explained.
“A variety of organizations have also expressed their views on the proposal,” he added. “This reflects the broad range of stakeholders, from industry groups to consumer advocates, who are invested in the future regulation of probiotics in foods and food/dietary supplements worldwide.”
Revision Underway
As a result of the debate, the proposal is being revised with the aim of refining the scope and definition of probiotics. It will also involve an evaluation by FAO/WHO on the need to update the 2001 guidelines to ensure they align with modern probiotic research and industry practices.
“The CCNFSDU44 session outcomes will undoubtedly have a significant influence on the future development of regulation at national level,” Jiménez concluded.